Overview

This trial is active, not recruiting.

Condition cancer
Treatment communication training and coaching
Sponsor University of Rochester
Collaborator National Cancer Institute (NCI)
Start date April 2011
End date September 2016
Trial size 470 participants
Trial identifier NCT01485627, 35388, R01CA140419-01A2

Summary

The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
communication training and coaching
Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
(No Intervention)
Patients will receive usual care

Primary Outcomes

Measure
Aim 1a Improved patient-physician-caregiver communication
time frame: 3 years
Aim 1 Prolonged grief symptoms (Caregiver Bereavement)
time frame: 4 years

Secondary Outcomes

Measure
Aim 1b&c Improved Patient-perceived communication
time frame: 3 years
Aim 2 Patient and Caregiver well-being
time frame: 3 years
Aim 2 Caregiver Physical Health Outcomes
time frame: 3 years
Aim 3 Health care utilization
time frame: 3 years

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: Physicians - Currently in clinical practice at participating institutions - Oncologist that cares for patients with solid tumors - Not planning to leave the practice during the next 6 months Inclusion Criteria: Patients - Currently a patient of an enrolled physician - Age 21 years or older - Diagnosis of advanced cancer - Able to understand spoken English (study personnel will read materials to low literacy patients) Inclusion Criteria: Caregivers - Caregiver of a patient currently enrolled in the study - Age 21 years or older - Able to understand spoken English (study personnel will read materials to low literacy patients) Exclusion Criteria: Physicians - Non Physicians and physicians who are not oncologists - Oncologists who exclusively care for patients with hematological malignancies - Prior involvement in health-related coaching interventions Exclusion Criteria: Patients - Unable to complete orally-administered surveys in English - Hospitalized or in hospice care at the time of recruitment - Prior involvement in health-related coaching interventions - Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma Exclusion Criteria: Caregiver Unable to complete orally-administered surveys in English

Additional Information

Official title Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
Principal investigator Ronald Epstein, MD
Description The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Rochester.